HR-positive, HER2-negative Breast CancerPhase 1/2NCT07730125
Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies
A Phase 1/2 study testing CRG-150 in people with HR-positive, HER2-negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by CoRegen, Inc..
Trial summary
The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Prostate Cancer
- What is being tested?
- CRG-150
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of understanding, and willing to comply with, and voluntarily sign and date an informed consent form (ICF).
- Willing to adhere to the study visit schedule and other protocol requirements, including the required apheresis procedure/blood collection.
- Is ≥18 years old at the time consent is obtained.
- Must have one of the following metastatic cancer diagnoses:
- HR+HER2- breast cancer
- TNBC
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- Prostate cancer
- Has received the following treatment lines for their disease, and in the opinion of the Investigator, the patient would unlikely tolerate or derive clinically meaningful benefit from available treatment options:
- Metastatic HR+HER2- breast cancer
- Patients previously treated for metastatic disease with at least two of the following: endocrine therapy (ET), CDK4/6 inhibitors, or antibody-drug conjugate, with disease progression or intolerance to therapy.
- Prior chemotherapy is not required but does not exclude the patient from the study.
- Metastatic TNBC (mTNBC, estrogen, progesterone, and human epidermal growth factor receptor 2 [HER2] negative)
- Patients previously treated for metastatic disease with at least two of the following: immunotherapy, antibody-drug conjugate, or chemotherapy with disease progression or intolerance to therapy.
- Metastatic prostate cancer (mPC)
- Previously treated for advanced or metastatic disease with the following, alone or in combination, and have demonstrated disease progression by PCWG3 and/or RECIST 1.1 by Investigator judgment, OR is intolerant to therapy:
- Patients previously treated for metastatic disease with at least two of the following: androgen deprivation therapy, oral androgen receptor pathway inhibitors, or taxane chemotherapy with disease progression or intolerance to therapy.
- Patient will be allowed if they refuse or are considered unfit for taxane chemotherapy.
- Has measurable disease as per RECIST 1.1 or bone-only disease (HR+HER2- breast cancer or TNBC only) OR by RECIST 1.1 or bone-only metastases with measurable prostate-specific antigen (PSA) (≥1 ng/mL) (mPC only).
- Has an ECOG performance status of 0 or 1 at screening.
- Has adequate organ function as defined by:
- Hematological parameters:
- Absolute neutrophil count (ANC) ≥1.0 × 109/L (1000/µL)
- Platelet count (PLT) ≥50.0 × 109/L (50,000/µL)
- Hemoglobin ≥7.0 g/dL
- Absolute lymphocyte count (ALC) >0.5 × 109/L (500/µL)
- Renal: Calculated creatinine clearance must be ≥40 mL/min/1.73 m2 (by the Chronic Kidney Disease Epidemiology Collaboration 2021 equation).
- Hepatic parameters:
- Serum total bilirubin ≤1.5x upper limit of normal (ULN) (or <3x ULN if liver metastases present or documented Gilbert's Syndrome).
- Aspartate aminotransferase (AST) ≤2.5x ULN; alanine aminotransferase (ALT) ≤2.5x ULN (AST, ALT ≤5x ULN if liver metastases present).
- Pulmonary: Oxygen saturation on room air >88% per pulse oximetry and not on supplemental oxygen.
- Cardiac: Hemodynamically stable and left ventricular ejection fraction ≥45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA).
- Has met the minimum washout time for previous cancer therapies before apheresis, and in the Investigator's judgment, the patient is able to safely undergo the apheresis.
- If a woman of childbearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use 2 effective contraceptive methods; examples include oral, parenteral, or implantable hormonal contraceptive, intra-uterine device, barrier contraceptive with spermicide, partner's latex condom or vasectomy) while on study treatment and for at least 1 year after the last dose of the study drug.
- If a WCBP, she must have a negative serum pregnancy test prior to the dose of the study drug.
- If male, a patient must agree to use a latex condom, even if he had a successful vasectomy, while on study treatment and for at least 1 year after the last dose of the study drug.
- If male, a patient must agree not to donate sperm, and if female, a patient must agree not to donate eggs for at least 1 year after the last dose of the study drug.
Who cannot join
- On systemic corticosteroid therapy (>5 mg prednisone daily or its equivalent) for an underlying condition (if they were receiving corticosteroid therapy (>5 mg prednisone daily or its equivalent), it must have been stopped >7 days prior to apheresis for cell manufacturing). Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed.
- Previous treatment with any investigational agent within 14 days of Screening Period.
- Has an active autoimmune disease (including but not limited to systemic lupus erythematosus, Sjögren's Syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 12 months (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Active malignancies other than the primary cancer indication, other than non-melanoma skin cancer or carcinoma-in-situ (cervix, bladder, or breast). Patients may be eligible if they have shown no evidence of active disease for two years prior to the first dose of the study drug.
- Clinically significant, active, uncontrolled, systemic infection; the following are not exclusionary:
- Patients with human immunodeficiency virus (HIV) must have been on effective antiretroviral therapy for ≥4 weeks prior to enrollment; must have an HIV viral load below the limits of detection; no acquired immunodeficiency syndrome-related opportunistic infections in the past 12 months; and a cluster of differentiation (CD)4+ cell count ≥350 cells/µL.
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- Patients with chronic hepatitis B virus (HBV) infection must be on antiviral therapy and have an HBV viral load below the limits of detection.
- Patients with chronic hepatitis C virus (HCV) infection must have completed therapy and have an HCV viral load below the limits of detection.
- Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to screening, or no recovery from side effects of such intervention, or has planned elective surgery.
- Presence of active and clinically relevant central nervous system disorder, such as epilepsy, stroke, or symptomatic or uncontrolled brain metastases.
- Patients with severe chronic diseases of the kidney, liver, heart, lung, or any other serious illness that, in the opinion of the Investigator, may affect the patient's therapies, follow up, or assessments, including but not limited to uncontrolled clinically significant neurological or psychiatric disorders or metabolic diseases.
- Has significant cardiac disease, such as recent (within 6 months prior to first dose of the study drug) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias, or severe aortic stenosis.
- Has a history of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within 6 months prior to the first dose of the study drug.
- Patients with deep vein thrombosis or pulmonary embolism initially diagnosed within 6 months prior to the first dose of the study drug may be eligible if they are appropriately treated with anticoagulants (or are off anticoagulants if no longer indicated) and have no evidence of such disease at Screening.
- Has mental or medical conditions that prevent the patient from giving informed consent or participating in the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study.
- Has known or suspected intolerance to the components of the study drug, such as dimethyl sulfoxide.
- Is concurrently participating in another investigational therapeutic clinical trial.
- Prior treatment with gene or cell therapy.
- Is a pregnant or breastfeeding female.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Suzanne Director, Clinical Operations contact
About this study
The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer. The main questions it aims to answer are:
Phase 1
Read more
- Incidence of DLTs
- Incidence of CRG-150 related AEs and SAEs
- Select the Recommended Phase 2 Dose (RP2D), as determined through the dose escalation process for the specified indications Phase 2a
- HR+HER2- Breast Cancer and TNBC: Overall Response Rate (ORR) (CR+PR) using FDG PET/CT and RECIST 1.1 by Investigator assessment
- Prostate Cancer: ORR per PCWG3-modified RECIST 1.1 by Investigator assessment
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
- CRG-150 cells at the assigned dose
Read the detailed description
This is a first-in-human, open-label, multicenter Phase 1/2a study of CRG-150, an autologous gene-edited Treg cell therapy that will follow a BOIN design of dose-escalating cohorts to determine a Recommended Phase 2 Dose (RP2D). Phase 2a participants will be treated with CRG-150 at the determined RP2D.
Following consent and screening assessments, enrolled participants will undergo an apheresis procedure to manufacture the autologous product. The time from apheresis to delivery of product back to the patient is anticipated to be approximately 28 days, and bridging therapy will be allowed between apheresis and CRG-150 infusion at the Investigator's discretion. No lymphodepleting chemotherapy will be administered prior to CRG-150 infusion.
Participants are followed for disease outcomes for 12 months and for long-term safety for up to 15 years, consistent with FDA guidance.
- Conditions
- HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Prostate Cancer
- Being tested
- CRG-150
- Keywords
- HR+HER2-Breast Cancer, Triple Negative Breast Cancer, TNBC, Prostate Cancer, relapsed/refractory, Treg, cell therapy, T Regulatory Cells, gene-edited, relapsed/refractory malignancies, Immunotherapy
- Medical subject headings
- Triple Negative Breast Neoplasms, Prostatic Neoplasms, Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRG-150Drug
autologous, gene-edited Treg cell therapy
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Drug: CRG-150 autologous cell therapy 3 escalating dose levels with 2 de-escalation dose levels are designed to explore the safety, tolerability, cellular kinetics and antitumor activity of CRG-150.
DL-1: 50 x 10e6 cells (de-escalation) DL1: 75 x 10e6 cells DL2: 375 x 10e6 cells DL2.5 (optional): 562 x 10e6 cells (de-escalation) DL3: 750 x 10e6 cells
Phase 2 expansion at RP2D: in HR+HER2- breast cancer, TNBC and/or Prostate Cancer. (10 participants per tumor type) Receives: Drug: CRG-150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with DLTs within 28 days from first infusion and overall safety
- The proportion of patients with DLTs occurring within 28 days from first cell infusion will be calculated for each dose level
- Overall safety: type, frequency, and severity of SAEs (IRRs, immune reactions, new malignancies, AEs leading to death, and DLTs), and of treatment-related AEs and systemic reactions
Measured: *DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years
Determine the recommended phase 2 dose (RP2D) of CRG-150
RP2D, as determined through the dose escalation process for the specified indications
Measured: Up to 1-year post-infusion
Secondary outcomes (3)
Cellular Kinetics: Presence, frequency, persistence and expansion of CRG-150 after infusion, by ddPCR
Patients will be monitored for expansion and persistence of CRG-150 after infusion by ddPCR analysis..
Measured: Expansion up to 12 months post-infusion with CRG-150; Persistence: up to 5 years after infusion with CRG-150
Efficacy: ORR in r/r HR+HER2- breast cancer and TNBC
The ORR is defined as the proportion of patients in CR or PR per RECIST 1.1 from the start of CRG-150 infusion until disease progression or initiation of new anticancer therapy.
Measured: Up to 12 months post-infusion of CRG-150
Efficacy: ORR in r/r prostate cancer
ORR is defined as the proportion of patients in CR or PR per PCWG3-modified RECIST 1.1 criteria prior to disease progression or the initiation of new anticancer therapy
Measured: Up to 12 months post-infusion with CRG-150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR-positive, HER2-negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase 1 * Dose levels 1, 2 and 3 (28-d dose-limiting toxicity (DLT) safety interval between dosing of the first participant and the next participant in each dose level cohort) Safety Review Committee (SRC) will review all available safety, efficacy and biomarker data to determine whether dose escalation should proceed to the next level * Proposed RP2D cohort * Optional backfill cohorts Phase 2a * Tumor-specific cohort expansion at the RP2D established from Phase 1 (No dose staggering required between participants) Phase 2a participants will be managed in an outpatient setting (with post-infusion observation of at least 4 hours)
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoRegen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Sonal Gupta, MD, Study director, CoRegen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730125
- Sponsor's protocol ID
- CoReg-001
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies
- ClinicalTrials.gov ID
- NCT07730125
- Acronym / sponsor ID
- CoReg-001
- Conditions
- HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Prostate Cancer
- Keywords
- HR+HER2-Breast Cancer, Triple Negative Breast Cancer, TNBC, Prostate Cancer, relapsed/refractory, Treg, cell therapy, T Regulatory Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- CoRegen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer. The main questions it aims to answer are:
Phase 1
- Incidence of DLTs
- Incidence of CRG-150 related AEs and SAEs
- Select the Recommended Phase 2 Dose (RP2D), as determined through the dose escalation process for the specified indications Phase 2a
- HR+HER2- Breast Cancer and TNBC: Overall Response Rate (ORR) (CR+PR) using FDG PET/CT and RECIST 1.1 by Investigator assessment
- Prostate Cancer: ORR per PCWG3-modified RECIST 1.1 by Investigator assessment
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
- CRG-150 cells at the assigned dose
Detailed description
This is a first-in-human, open-label, multicenter Phase 1/2a study of CRG-150, an autologous gene-edited Treg cell therapy that will follow a BOIN design of dose-escalating cohorts to determine a Recommended Phase 2 Dose (RP2D). Phase 2a participants will be treated with CRG-150 at the determined RP2D.
Following consent and screening assessments, enrolled participants will undergo an apheresis procedure to manufacture the autologous product. The time from apheresis to delivery of product back to the patient is anticipated to be approximately 28 days, and bridging therapy will be allowed between apheresis and CRG-150 infusion at the Investigator's discretion. No lymphodepleting chemotherapy will be administered prior to CRG-150 infusion.
Participants are followed for disease outcomes for 12 months and for long-term safety for up to 15 years, consistent with FDA guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 * Dose levels 1, 2 and 3 (28-d dose-limiting toxicity (DLT) safety interval between dosing of the first participant and the next participant in each dose level cohort) Safety Review Committee (SRC) will review all available safety, efficacy and biomarker data to determine whether dose escalation should proceed to the next level * Proposed RP2D cohort * Optional backfill cohorts Phase 2a * Tumor-specific cohort expansion at the RP2D established from Phase 1 (No dose staggering required between participants) Phase 2a participants will be managed in an outpatient setting (with post-infusion observation of at least 4 hours)
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: CRG-150Drug: CRG-150 autologous cell therapy 3 escalating dose levels with 2 de-escalation dose levels are designed to explore the safety, tolerability, cellular kinetics and antitumor activity of CRG-150. DL-1: 50 x 10e6 cells (de-escalation) DL1: 75 x 10e6 cells DL2: 375 x 10e6 cells DL2.5 (optional): 562 x 10e6 cells (de-escalation) DL3: 750 x 10e6 cells Phase 2 expansion at RP2D: in HR+HER2- breast cancer, TNBC and/or Prostate Cancer. (10 participants per tumor type) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Capable of understanding, and willing to comply with, and voluntarily sign and date an informed consent form (ICF).
- Willing to adhere to the study visit schedule and other protocol requirements, including the required apheresis procedure/blood collection.
- Is ≥18 years old at the time consent is obtained.
- Must have one of the following metastatic cancer diagnoses:
- Has received the following treatment lines for their disease, and in the opinion of the Investigator, the patient would unlikely tolerate or derive clinically meaningful benefit from available treatment options:
Key exclusion criteria (19 listed)
- On systemic corticosteroid therapy (>5 mg prednisone daily or its equivalent) for an underlying condition (if they were receiving corticosteroid therapy (>5 mg prednisone daily or its equivalent), it must have been stopped >7 days prior to apheresis for cell manufacturing). Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed.
- Previous treatment with any investigational agent within 14 days of Screening Period.
- Has an active autoimmune disease (including but not limited to systemic lupus erythematosus, Sjögren's Syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 12 months (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Active malignancies other than the primary cancer indication, other than non-melanoma skin cancer or carcinoma-in-situ (cervix, bladder, or breast). Patients may be eligible if they have shown no evidence of active disease for two years prior to the first dose of the study drug.
- Clinically significant, active, uncontrolled, systemic infection; the following are not exclusionary:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRG-150autologous, gene-edited Treg cell therapy | Drug | Dose Escalation |
Primary outcome
Proportion of patients with DLTs within 28 days from first infusion and overall safety
Time frame: *DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years
* The proportion of patients with DLTs occurring within 28 days from first cell infusion will be calculated for each dose level * Overall safety: type, frequency, and severity of SAEs (IRRs, immune reactions, new malignancies, AEs leading to death, and DLTs), and of treatment-related AEs and systemic reactions
Determine the recommended phase 2 dose (RP2D) of CRG-150
Time frame: Up to 1-year post-infusion
RP2D, as determined through the dose escalation process for the specified indications
3 secondary outcomes
Cellular Kinetics: Presence, frequency, persistence and expansion of CRG-150 after infusion, by ddPCR
Time frame: Expansion up to 12 months post-infusion with CRG-150; Persistence: up to 5 years after infusion with CRG-150
Efficacy: ORR in r/r HR+HER2- breast cancer and TNBC
Time frame: Up to 12 months post-infusion of CRG-150
Efficacy: ORR in r/r prostate cancer
Time frame: Up to 12 months post-infusion with CRG-150
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Director, Clinical Operations contact
Sonal Gupta, MD study director
CoRegen, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CRG-150 in people with HR-positive, HER2-negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by CoRegen, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerry VP, Clinical Operations (1-832-900-4560, clinicalinfo@coregen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with DLTs within 28 days from first infusion and overall safety (time frame: *DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.